SuperGen and MGI PHARMA Announce Filing of MAA for Approval of Dacogen(TM) in Europe
01 Octubre 2004 - 9:18AM
PR Newswire (US)
SuperGen and MGI PHARMA Announce Filing of MAA for Approval of
Dacogen(TM) in Europe DUBLIN, Calif. and MINNEAPOLIS, Oct. 1
/PRNewswire-FirstCall/ -- SuperGen, Inc. (NASDAQ:SUPG) and MGI
PHARMA, INC. (NASDAQ:MOGN), today announced that a Marketing
Authorization Application (MAA) seeking approval of Dacogen(TM)
(decitabine) for injection has been submitted to the European
Agency for the Evaluation of Medicinal Products (EMEA) by
SuperGen's European subsidiary, EuroGen Pharmaceuticals Ltd.
Dacogen is the Company's investigational anti-cancer therapeutic
for the treatment of patients with myelodysplastic syndromes or
MDS. MGI PHARMA has exclusive worldwide rights to the development,
manufacture, commercialization and distribution of Dacogen. "We are
very pleased to have completed this regulatory milestone for
Dacogen," said Dr. James Manuso, President and Chief Executive
Officer of SuperGen. "SuperGen remains committed to bringing
Dacogen to patients as quickly as possible, with the support of our
new partner, MGI PHARMA." "The MAA submission for Dacogen marks a
key regulatory milestone," said Lonnie Moulder, President and Chief
Executive Officer of MGI PHARMA. "We believe that Dacogen will
become an important treatment option for hematologic cancer
patients, and we look forward to the upcoming U.S. NDA filing as
the next regulatory milestone." SuperGen completed Phase III
clinical trials of Dacogen in patients with MDS in March 2004.
SuperGen and MGI are collaborating on the regulatory development
process for Dacogen in MDS, and expect to complete the NDA filing
during the fourth quarter of 2004. MGI PHARMA plans to initiate a
Phase III trial of Dacogen for the treatment of acute myelogenous
leukemia (AML) in early 2005 and plans to evaluate Dacogen for
further development in other hematologic malignancies. Alternative
dosing schedules for Dacogen, including subcutaneous administration
and more rapid intravenous infusions, are currently being evaluated
in clinical studies. About Dacogen Dacogen is an investigational
drug. It has not yet been approved for marketing in the U.S. or by
other regulatory agencies in their respective countries; therefore,
safety and efficacy have not yet been established in any patient
population. In clinical trials, Dacogen has been shown to have a
broad spectrum of activity in several hematological malignancies as
well as solid tumors. Dacogen belongs to a class of drugs called
hypomethylating agents, with a unique mechanism of action.
Methylation is a process in which methyl (CH3) groups are added to
DNA which may inactivate or "silence" tumor suppressor genes. About
MDS MDS is a cancer of the bone marrow that is often fatal. Some
cases of MDS progress to leukemia. According to the Aplastic Anemia
and MDS International Foundation (http://aamds.org/), 20,000 to
30,000 new cases of MDS are diagnosed annually in the United
States. The number of new cases diagnosed each year is increasing.
The average life expectancy for patients diagnosed with MDS is 6
months to 5 years, depending on the severity of the disease. About
SuperGen Based in Dublin, California, SuperGen is a pharmaceutical
company dedicated to the acquisition, rapid development and
commercialization of therapies for solid tumors, hematological
malignancies and blood disorders. SuperGen's product portfolio
includes Orathecin(TM) (rubitecan) capsules, an investigational
drug intended for the treatment of pancreatic cancer; Nipent(R)
(pentostatin for injection); Mitomycin (generic brand of
Mitomycin(R)); and SurfaceSafe(R) cleaner. For more information
about SuperGen, please visit http://www.supergen.com/. About MGI
PHARMA MGI PHARMA, INC. is an oncology-focused biopharmaceutical
company that acquires, develops and commercializes proprietary
products that address the unmet needs of cancer patients. MGI
PHARMA has a portfolio of proprietary pharmaceuticals, and intends
to become a leader in oncology. MGI PHARMA markets Aloxi(R)
(palonosetron hydrochloride) injection, Salagen(R) Tablets
(pilocarpine hydrochloride) and Hexalen(R) (altretamine) capsules
in the United States. The Company directly markets its products in
the U.S. and collaborates with partners in international markets.
For more information about MGI PHARMA, please visit
http://www.mgipharma.com/. This news release contains certain
"forward-looking" statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements are
typically preceded by words such as "believes," "expects,"
"anticipates," "intends," "will," "may," "should," or similar
expressions, and include statements regarding the timing of the
submission of an NDA for Dacogen to the U.S. Food and Drug
Administration. These forward-looking statements are not guarantees
of MGI PHARMA's or SuperGen's future performance and involve a
number of risks and uncertainties that may cause actual results to
differ materially from the results discussed in these statements.
Factors that might cause either company's results to differ
materially from those expressed or implied by such forward-looking
statements include, but are not limited to, whether a submission
for regulatory approval for Dacogen will be made in the U.S. in a
timely fashion, if at all; whether the drug will be timely
approved, if at all in any country where a submission is made;
whether the drug, if approved will be successfully commercialized;
continued sales of MGI PHARMA's or SuperGen's other marketed
products; development or acquisition of additional products;
reliance on contract manufacturing and third party suppliers;
changes in strategic alliances; and other risks and uncertainties
detailed from time to time in either company's filings with the
Securities and Exchange Commission, including their most recently
filed Forms 10-Q or 10-K. MGI PHARMA and SuperGen undertake no duty
to update any of these forward- looking statements to conform them
to actual results. CONTACT: For further information about MGI
PHARMA, please contact: Jennifer Davis David Melin MGI PHARMA -
Investors MGI PHARMA - Media Tel: (212) 697-1976 Tel: (952)
346-4749 E-mail: E-mail: For further information about SuperGen,
please contact: Timothy L. Enns Sharon Weinstein SuperGen, Inc.
Euro RSCG Life NRP Tel: (925) 560-0100 x111 Tel: (212) 845-4271
E-mail: E-mail: DATASOURCE: SuperGen, Inc.; MGI PHARMA, INC.
CONTACT: Jennifer Davis - Investors, +1-212-697-1976, , or David
Melin - Media, +1-952-346-4749, ; Timothy L. Enns, SuperGen, Inc.,
+1-925-560-0100 x111, ; Sharon Weinstein, Euro RSCG Life NRP,
+1-212-845-4271, , for SuperGen, Inc. Web site:
http://www.supergen.com/ http://www.mgipharma.com/
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